The main purpose of study is checking the effect of Chamomile on pain of breast in women with cyclic Mastalgia. Subjects in study are women aged 18 to 45 years and must have cyclic mastalgia. Target sample size is 60 patients. Initial examination will be done by resident of Gynecology. If any suspicious mass be observed, mammogram or ultrasound must be done. All women more than 40 years should have mammogram or ultrasound during the past year. Women with benign or malignant disease؛ pregnant؛ lactating؛ using Steroid drugs؛ Danazol؛ Vit B6؛ Bromocriptine and Aspirin will be excluded from study. Visual Analogue Scale will be used and patients with pain for more than 5 days will be chosen as sample. Randomization will be done. Chamomile and pelacebo is used 5drops, 3 times a day for 2 cycle since the beginning to the end of menstrual cycle. At the end of study, questionnarei and examination will be done. Posible side effects include allergic reactions in sensitive people.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016092525967N2
Registration date:2016-10-29, 1395/08/08
Registration timing:retrospective
Last update:
Update count:0
Registration date
2016-10-29, 1395/08/08
Registrant information
Name
Fahime Vafisani
Name of organization / entity
Ferdosi University
Country
Phone
Email address
fahimevafisani@yahoo.com
Recruitment status
Recruitment complete
Funding source
Deputy for Research Mashhsad University of Medical Sciences
Expected recruitment start date
2015-05-23, 1394/03/02
Expected recruitment end date
2015-11-19, 1394/08/28
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of Chamomile compaired to pelacebo on cyclic mastalgia in women
Public title
The effect of Chamomile on cyclic mastalgia in women
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: aged 18 to 45 years؛ pain of breast stsrted 2 weeks before menstruation and pain reduced with menstruation؛ approximate regular menstrual periods in recent 3 rounds
Exclusion criteria: Underlying disease of uterin؛ breast and hormonal؛ pregnancy؛ lactating and menopause؛ using sex steroids؛ Danazol؛ oil of evening primrose؛ vitamin B6؛ NSAIDs؛ Bromocriptine؛ Selective Estrogen Receptor Inhibitors؛ regular use of Aspirin or other trearments to reduce pain of breast over the past two months.
Age
From 18 years old to 45 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Depty for Research Mashhad University of Medical Sciences
Street address
Ghoreshi Building, In front of the 18th Daneshgah Avenue, Daneshgah Street
City
Mashhad
Postal code
11111-11111
Approval date
2013-10-19, 1392/07/27
Ethics committee reference number
IR.MUMS.REC.1392.152
Health conditions studied
1
Description of health condition studied
Mastodynia
ICD-10 code
N64.4
ICD-10 code description
Mastodynia
Primary outcomes
1
Description
Mastalgia
Timepoint
Before and after the intervention
Method of measurement
Using Visual Analogue Scale
Secondary outcomes
1
Description
Sensitivity to placebo or camomile
Timepoint
Before and after intervention
Method of measurement
Blood test
Intervention groups
1
Description
In main group, patients with moderate to severe pain of breast enter to the study. Chamomile were used 5 drops, 3 times a day for two cycle since the beginning to the end of the menstrual cycle. At the end of study, breasts were examined.
Category
Treatment - Drugs
2
Description
In intervention group, patients with moderate to severe pain of breast enter to the study. Pelacebo were used 5 drops, 3 times a day for two cycle since the beginning to the end of the menstrual cycle. At the end of study, breasts were examined.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Ghaem Hospital
Full name of responsible person
Masumeh Ghazanfarpour
Street address
Ghaem Hospital, Taghi Abad Square, Ahmad Abad Street
City
Mashhad
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Deputy for Research Mashhad University of Medical Sciences
Full name of responsible person
Dr.Mohsen Tafaghodi
Street address
Ghoreshi Building, In front of the 18th Daneshgah Avenue, Daneshgah Street
City
Mashhad
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Deputy for Research Mashhad University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Masumeh Ghazanfarpour
Position
PhD Student of Pregnancy health
Other areas of specialty/work
Street address
College of Nursing and Midwifery, Doctora Crossroads
City
Mashhad
Postal code
45436-88969
Phone
+98 51 3859 1511
Fax
Ghazanfarpm901@mums.ac.ir
Email
GHAZANFARPM901@MUMS.AC.IR
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Masumeh Ghazanfarpour
Position
PhD Student of Pregnancy health
Other areas of specialty/work
Street address
College of Nursing and Midwifery, Doctora Crossroads
City
Mashhad
Postal code
45436-88969
Phone
+98 51 3859 1511
Fax
Ghazanfarpm901@mums.ac.ir
Email
GHAZANFARPM901@MUMS.AC.IR
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Fahime Vafi Sani
Position
Masters Student of Nutrition
Other areas of specialty/work
Street address
Medical college, Vakil Abad Street
City
Mashhad
Postal code
57899-45147
Phone
+98 51380022024
Fax
+98 51380022024
Email
Fahimevafisani@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)